Clinical trial · Interventional
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F-DCFPyL Injection | Drug | — | UNRESOLVED |
| PSMA PET | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radioactive Diagnostic Imaging
- description
- Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.
- interventionNames
- Drug: F-DCFPyL Injection
- Diagnostic Test: PSMA PET
Primary outcomes (1)
- measure
- Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
- timeFrame
- Up to 5 years
- description
- To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
Secondary outcomes (1)
- measure
- Rate of Positive PSMA-PET Findings
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1 * Previously enrolled to MCC#18523 * Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen * Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\>0.45) * Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up * Age \> 18 Exclusion Criteria: * No follow up information available post treatment * Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia * Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
References
Publications (0)
Data not yet available